# Post-market surveillance plan (outline)

**Device:**  
**Jurisdiction(s):**  
**Date:**  
**Owner:**

## Data sources

- Complaints and feedback:
- Service / device logs (privacy compliant):
- Literature and comparable incidents:
- Registries or real-world data (if applicable):

## Indicators and thresholds

| Indicator | Method | Threshold | Action |
|-----------|--------|-----------|--------|
| | | | |

## AI / software-specific monitoring

- Model performance drift metrics:
- PCCP-bound changes vs out-of-bounds triggers:

## Reporting

- Mandatory reporting routes (confirm with RA):
- Internal executive cadence:

## PMS report / summary outputs

- Annual summary owner and storage location: